Maxine MoirKidney Transplant Recipient
Reginald Seeto, MB.BS – President and Chief Business Officer – CareDx, Inc.
Evolutions In Transplantation:Blood Tests That Measure Graft Rejection
May 21st, 2019
Joyanne F. – Kidney Transplant Recipient,
AlloSure Patient
• 20 Years of dedication to transplantation
– Believes in partnering with transplant centers and the transplant community
– Builds a sustainable transplant company - “Unicorn” in transplantation
CareDx in a Nutshell
• Has become a leader in science in transplant diagnostics
– Advances science based on multi-center clinical trials
– Believes in peer reviewed publications in high impact journals
• Focused on patients and long-term outcomes
– Committed to innovation in transplant care
– Delivering meaningful products and services for transplant patients
Paul Conway AAKPAngelica Hale
Ally Babineaux
Edward Drake, II
Nichole Jefferson
Patient Guest Speakers
Joseph Cepeda
Wilson Du
DerekForfang
DavidWhite
TedConrads
DorisLew
LenoraCoss
JoanneGarcia
JohnCabaluna
CareDx Patient Symposium January 2019
Honor the Gift Campaign
Sign the pledge www.honorthegift.org
Honor the Gift is a national patient-centered campaign,
supported by CareDx and promoted by a coalition of
kidney and transplant organizations, focused on
extending Medicare coverage of immunosuppressive
medication for kidney transplant recipients beyond the
current three-year cap.
OUR VISIONThe Leading Partner forTransplant Patients andThe Transplant Ecosystem
Better Matching + Better Surveillance=
Better Outcomes
CareDx Focuses on Long-Term Outcomes
10
Conceptual
Source: Team Analysis
Current Survival
Future Survival
Years
13
Complianceand
Adherence
Standardization and
Personalization
ImmunoModulation
CareDx – 20 Years of Focus on Transplantation
Evolution during last 5 years to deliver on Vision
2014 2019
AlloMap Business
Building dd-cfDNA technology platform (ImmuMetrix)
Acquired pre-transplant business (Allenex)
Acquired ex-Conexio / Illumina SBT
License NGS Tx- Portfolio (Illumina)
Launched AlloSure first dd-cfDNA
Leader Heart Tx
TODAY
Pre-TxBusiness
LeaderRenal Tx
Pipeline /Platform
Global operations
TransplantLeader
Launched QTYPE (PCR HLA)
Launched Heartcare (via SHORE)
…
Ongoing Unmet Needs in Transplantation
Laying Foundation to Lead in Patient Care Management Evolution during next 12 months for Longitudinal and long-term patient management
Launched HeartCare and AlloSure Lung
Launch Kidney Care (AlloSure, AlloMap, and i-BOX)
Partner for i-BOX Technology, first step towards Artificial Intelligence
Acquired OTTR with bioinformatics capabilities
Launch AlloSeq BMT- new technology for this field
Launch AlloSeq Tx17- next leap forward in NGS HLA Typing
Leader Heart
Today
LeaderRenal Tx
Leader HLA Typing
Pipeline /Platform
Global operations
New platform partnerships
New pipeline programs- Tx specific
Expand ex-US offerings (e.g. AlloSeq cfDNA)
Launch new global offerings (e.g. AlloSeq BMT)
Leader in Kidney, Heart and Lung Tx
2019+
Leader in Artificial Intelligence
Leader in disruptive innovation
Leader along the Transplant Patient Journey
Global Leader in the field of Transplantation
Leader in long-term patient outcomes
Our Approach to Precision Medicine in Transplantation
AlloMapAlloSure- High Value - Proprietary
HeartCareKidneyCare- Multimodality- Protocolized Surveillance- Prognostic
GenomicBiomarkers
TransplantCare
ArtificialIntelligenceTransplant
Care
• Surveillance Standard• Multi-Center Trials
• Decision Support• Individualized Care
AiTraC- Comprehensive
- Actionable Care Pathways
- Integrated into EMR
• Clinical Validation• Reimbursement
CareDx – Your Dedicated Partner in Transplant Care
Heart
Kidney
Lung
BMT
TestingService
Surveillance Products
TBD
Assign
Score6
TypingProducts
SoftwareSolutions
AlloSeq® Tx 17
AlloSeq® HLA
AlloMap Variability Score
2019 Plan
2019 New
2019 Coming
There is an increase in dd-cfDNA when there is injury to the transplanted kidney
Donor Derived Cell Free DNA (dd-cfDNA) increases with allograft injury
1. Grskovic M et al. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016;18(6):890-902.
2. Bloom RD et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017. doi:10.1681/ASN2016091034.
Case Example: Rationale for Disruptive Technology
1. Rao PS, Schaubel DE, Jia X, et al. Survival on dialysis post-kidney transplant failure: Results from the Scientific Registry of Transplant Recipients. Am J Kidney Dis. 2007;49:294-300
2. GAO report to Congressional requesters. End-stage renal disease. Characteristics of kidney transplant recipients, frequency of transplant failures, and cost to Medicare. 2007. GAO-07-1117.
Clinical Context: Loss of a Transplanted Kidney is a Major Issue for Transplant Recipients
CareDx Developed AlloSure to Assess Organ Health by Directly and Non-Invasively Measuring Allograft Injury
AlloSure provides significant utility in the early diagnosis, assessment, and management of allograft rejection
Current Transplant Surveillance Options Have Limitations in Diagnosing Rejection
• Current surveillance options– Creatinine:
• May increase for reasons such as dehydration
• May increase only after significant kidney injury
– Donor Specific Antibody (DSA)• Poorly predicts antibody
mediated rejection
– Biopsy• Expensive
• Inconvenient
• Interpretation is challenging
AlloSure is a Blood Test that can Provide Non-Invasive and Accurate Rejection Surveillance
AlloSure Outperforms Serum Creatinine for Detecting Active Rejection
Bloom RD et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017. doi:10.1681/ASN.2016091034.
* In patients with clinical suspicion of active rejection, the most common cause for the clinical suspicion of active rejection was elevated serum creatinine
AlloSure: First and only Clinically and Analytically Validated dd-cfDNA Test for Identifying Kidney Injury
1. De Vlaminck STM 2014 (heart), Grskovic JMD 2016 (heart), Bromberg JALM 2017 (kidney), Schutz PLOS Med 2017 (liver)2, 3. De Vlaminck STM 2014 (heart), Grskovic JMD 2016 (heart), Schutz PLOS Med 2017 (liver), Bloom JASN 2017 (kidney)4. De Vlaminck STM 2014 (heart), Grskovic JMD 2016 (heart), Brennan AJT 2017 (kidney, abstract)
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We Care About Strong Clinical Data and
Evidence in Transplantation
• Long-term dedication, trailblazer
• Partnering with Transplant Centers
• Large Multicenter studies
• Peer reviewed Publications
• Supports Innovation in Transplant Care
Commitment to Evidence & Clinical Data High Value Diagnostics
PUBLISHEDNov 2018
Use in Repeat Kidney Transplant
OUR VISIONThe Leading Partner forTransplant Patients andThe Transplant Ecosystem